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510(k) Data Aggregation
(90 days)
The Model 306 iGo Portable Oxygen Concentrator System is indicated for the administration of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities.
The model 306 Series oxygen concentrator system is a device that produces an oxygen enriched gas mixture by drawing in room air and extracting nitrogen, thus allowing oxygen to be delivered at a range of prescribed flows to patients with low oxygen saturation levels in the blood. The 306 Series is light weight and can operate on an external battery pack, features which allow the 306 Series to be readily transported by the patient. It has two operating modes: continuous product flow at up to 3 LPM and pulse dosage mode at settings of 1 to 6. In pulse dosage mode, the concentrator delivers a bolus of oxygen at each inhalation in an amount equal to 14cc times the setting value.
The provided text describes a 510(k) submission for the DeVilbiss Portable Oxygen Concentrator System (Model 306 Series). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way one might see for a diagnostic AI device.
Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this type of regulatory document. The primary "acceptance criteria" here relate to meeting established engineering and safety standards and demonstrating equivalent performance to the predicate device.
Here's the information that can be extracted, and where information is not available, it is noted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Oxygen Concentration | No less than 91% +/- 3% enriched gaseous oxygen concentration | Met: Device generates "no less than 91% +/-3% enriched gaseous oxygen concentration" |
| Flow Rates | Delivers flow rates between 0.5 and 6 liters per minute | Met: Device delivers "flow rates between .5 and 6 liters per minute of oxygen" |
| Operating Modes | Continuous product flow up to 3 LPM; Pulse dosage mode at settings 1-6 (14cc per setting value per inhalation) | Met: Device has "two operating modes: continuous product flow at up to 3 LPM and pulse dosage mode at settings of 1 to 6. In pulse dosage mode, the concentrator delivers a bolus of oxygen at each inhalation in an amount equal to 14cc times the setting value." |
| Safety Standards | Tested and approved to recognized safety standards (ISO, ASTM, IEC, FDA Guidance) | Met: "This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols." The device "met the required performance criteria and functioned as intended." |
| Equivalence | Functionally equivalent to the existing legally marketed predicate device (Sequal Eclipse Portable Oxygen Concentrator - K013931) | Met: "The DeVilbiss Portable Oxygen Concentrator is equivalent in functional characteristics to the existing legally marketed predicate device." "Analysis of comparison of design, function and features... together with the results of testing demonstrates the device to be substantially equivalent to the predicate device." |
| New Technologies | No new technologies introduced | Met: "No new technologies have been introduced in the DeVilbiss Portable Oxygen Concentrator." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided: This document describes non-clinical engineering and performance testing against standards and a predicate device, not a human-data-based clinical study test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable/Not Provided: Ground truth in the context of expert consensus is not relevant for this type of device submission. Performance is measured against engineering specifications and regulatory standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: This type of adjudication is for human expert agreement, which is not relevant here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This product is a portable oxygen concentrator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This product is a portable oxygen concentrator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For oxygen concentration and flow rates: Measured engineering specifications (e.g., sensor readings, flow meters).
- For safety and performance: Compliance with recognized ISO, ASTM, IEC standards, and FDA guidance documents.
8. The sample size for the training set
- Not Applicable/Not Provided: This document describes a medical device, not a machine learning model, so there is no "training set" in that context.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: As above, no training set for a machine learning model.
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